Intensive Care UnitsCASBANCT06999863
Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm
An observational study of Intensive Care Units, run by Nantes University Hospital at 1 site in France.
Trial summary
For accurate measurements of arterial blood pressure (BP), international guidelines recommend placing the automated oscillometric cuff directly on the bare upper arm. However, for various reasons, cuffs are often applied over a layer of textile. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intensive Care Units
- What is being tested?
- Patients of a surgical intensive care unit
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2025to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of a surgical intensive care unit having an arterial catheter
Who may be able to join
- - Patients having a catheter in the radial artery.
- and with stable BP over a 5-min period (no change in invasive MBP >10% and no change in vasoactive drugs)
Who cannot join
- - Cardiac arrhythmia.
- Dysfunctional of the arterial catheter or waveform, suggesting signal over- or under-damping.
- Arm circumference > 42 cm (measured at mid-arm).
- Contraindication to BP measurement on the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access on the limb preventing cuff inflation, other).
- Patient's health status requiring urgent care incompatible with study protocol.
- Asymmetry of MBP between the two arms (>5 mmHg) or inability to check it.
Show all 11Show fewer
- Pregnant woman.
- Age <18 years old.
- Adult known to be under guardianship or legal supervision before inclusion.
- Absence of social security coverage.
- Non-French speaker patient (i.e. unable to receive study information)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurements of Arterial Blood Pressure With an Automated Oscillometric Cuff: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm. A Prospective Observational Single-center Study With an Invasive Reference
For accurate measurements of arterial blood pressure (BP), international guidelines recommend placing the automated oscillometric cuff directly on the bare upper arm. However, for various reasons, cuffs are often applied over a layer of textile. Whether this practice affects the reliability of the readings remains uncertain. Using a rigorous methodology, the CASBA study aims at addressing this issue.
Additionally, two different BP measurement algorithms are available in some oscillometric monitors. To our knowledge, no study has compared the performance of these two algorithms. This study will help determine which oscillometric algorithm should be given priority in intensive care facilities.
Read the detailed description
The automated oscillometric cuff is the predominant non-invasive method for measuring BP. For accurate measurements, international guidelines recommend placing the cuff directly on a bare upper arm. However, for reasons of convenience, hygiene, comfort, cultural or religious practices, or skin reactions, cuffs are often applied over a layer of textile. Some authors suggest this practice does not significantly affect BP readings, while other authors are more cautious or even advise against it. Prior studies are not devoid of limitations. Further research into sleeve effects on BP measurement accuracy is warranted. The present study project employs rigorous methodology and leverages invasive arterial catheters for reliable reference measurements. Additionally, the broad range of BP levels in surgical intensive care units ensures comprehensive data, including mean, systolic, and diastolic BP (MBP, SBP, and DBP).
Additionally, some oscillometric monitors incorporate two reference algorithms for BP measurement:
- Auscultatory Reference Algorithm: Calibrates oscillometric measurements to align with manual cuff and stethoscope values. This is the default setting.
- Invasive Reference Algorithm: Adjusts non-invasive BP values to approximate invasive measurements.
Health care providers are, in our experience, rarely aware of the existence of these two distinct algorithms. Although the reference auscultatory algorithm is generally recommended for routine non-invasive monitoring, such as at home or in a clinic, the invasive reference algorithm might be preferable in critical care settings. Importantly, in the absence of published studies on the subject, these considerations remain speculative.
However, it is important to determine which oscillometric algorithm should be prioritized in critical care settings, where invasive measurement serves as the reference. This will be a secondary objective of this study.
- Conditions
- Intensive Care Units
- Being tested
- Patients of a surgical intensive care unit
- Keywords
- Blood pressure determination (MeSH), Bare arm, Sleeve, Measurement algorithm, Catheterization, peripheral arterial (MeSH), Cuff, Oscillometry (MeSH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients of a surgical intensive care unitOther
Patients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of BP in 3 situations (thick sleeve, thin sleeve, bare arm) and with 2 algorithms (for bare arm measurement only).
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
The reference BP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one
Measured: Day 1
Secondary outcomes (13)
To assess whether the non-invasive SBP and DBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg.
The reference BP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one.
Measured: Day 1
To perform statistical comparisons of measurement errors based on sleeve presence, sleeve thickness, and reference algorithm.
A p-value < 0.05 will be used as the threshold for statistical significance in comparisons.
Measured: Day 1
To assess the risk associated with measurement errors for each condition.
Via a dedicated error grid, the risk associated with measurement errors was classified into one of the 5 risk levels ranging from "no risk" to "dangerous risk". Distribution across the different risk levels was compared by Fisher exact tests.
Measured: Day 1
To compare the ability of non-invasive measurements to detect hypotension (MBP or SBP <65 mmHg or <90 mmHg, respectively) and hypertension (MBP or SBP >90 mmHg or >140 mmHg, respectively).
The ability of averaged noninvasive measurements to detect hypotension (invasive MBP <65 mmHg, SBP <90 mmHg), hypertension (invasive MBP>100 mmHg, SBP >140 mmHg), and a significant therapy-induced change in invasive MBP (>10%) was determined through area under the receiver operating characteristic curve (AUCROC) analysis.
Measured: Day 1
To evaluate variability in cuff measurements within a given condition.
Measurement variability will be assessed using the coefficient of variation. The clinical performance of an average of multiple measurements will also be compared to that of a single measurement.
Measured: Day 1
Analysis of subgroup differences based on BP levels (above vs. below median values).
The primary evaluation criteria will be applied to subgroup analyses for each BP component.
Measured: Day 1
Analysis of subgroup differences based on measurement error levels (above vs. below median values)
The primary evaluation criteria will be applied to subgroup analyses for each BP component.
Measured: Day 1
Analysis of subgroup differences based on BMI (above vs. below median and above vs. below 30 kg/m²)
The primary evaluation criteria will be applied to subgroup analyses for different BMI ranges.
Measured: Day 1
Analysis of subgroup differences based on arm circumference (above vs. below median)
The primary evaluation criteria will be applied to subgroup analyses for varying arm circumferences.
Measured: Day 1
Analysis of subgroup differences based on age (above vs. below 60 years)
The primary evaluation criteria will be applied to subgroup analyses for different classes of ages
Measured: Day 1
Analysis of subgroup differences based on age (above vs. below 60 years)
The primary evaluation criteria will be applied to subgroup analyses for different classes of ages.
Measured: Day 1
Analysis of subgroup differences based on presence of acute circulatory failure or not
The primary evaluation criteria will be applied to subgroup analyses according to acute circulatory failure or not.
Measured: Day 1
Analysis of subgroup differences based on ventilation mode (mechanical vs. non-mechanical)
The primary evaluation criteria will be applied to subgroup analyses according to the ventilation mode
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start24 Jul 2025
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim LAKHAL, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999863
- Sponsor's protocol ID
- RC25_0025
- Acronym
- CASBA
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Arterial Blood Pressure With an Automated Oscillometric Cuff: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm. A Prospective Observational Single-center Study With an Invasive Reference
- ClinicalTrials.gov ID
- NCT06999863
- Acronym / sponsor ID
- CASBA / RC25_0025
- Conditions
- Intensive Care Units
- Keywords
- Blood pressure determination (MeSH), Bare arm, Sleeve, Measurement algorithm, Catheterization, peripheral arterial (MeSH), Cuff, Oscillometry (MeSH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For accurate measurements of arterial blood pressure (BP), international guidelines recommend placing the automated oscillometric cuff directly on the bare upper arm. However, for various reasons, cuffs are often applied over a layer of textile. Whether this practice affects the reliability of the readings remains uncertain. Using a rigorous methodology, the CASBA study aims at addressing this issue.
Additionally, two different BP measurement algorithms are available in some oscillometric monitors. To our knowledge, no study has compared the performance of these two algorithms. This study will help determine which oscillometric algorithm should be given priority in intensive care facilities.
Detailed description
The automated oscillometric cuff is the predominant non-invasive method for measuring BP. For accurate measurements, international guidelines recommend placing the cuff directly on a bare upper arm. However, for reasons of convenience, hygiene, comfort, cultural or religious practices, or skin reactions, cuffs are often applied over a layer of textile. Some authors suggest this practice does not significantly affect BP readings, while other authors are more cautious or even advise against it. Prior studies are not devoid of limitations. Further research into sleeve effects on BP measurement accuracy is warranted. The present study project employs rigorous methodology and leverages invasive arterial catheters for reliable reference measurements. Additionally, the broad range of BP levels in surgical intensive care units ensures comprehensive data, including mean, systolic, and diastolic BP (MBP, SBP, and DBP).
Additionally, some oscillometric monitors incorporate two reference algorithms for BP measurement:
- Auscultatory Reference Algorithm: Calibrates oscillometric measurements to align with manual cuff and stethoscope values. This is the default setting.
- Invasive Reference Algorithm: Adjusts non-invasive BP values to approximate invasive measurements.
Health care providers are, in our experience, rarely aware of the existence of these two distinct algorithms. Although the reference auscultatory algorithm is generally recommended for routine non-invasive monitoring, such as at home or in a clinic, the invasive reference algorithm might be preferable in critical care settings. Importantly, in the absence of published studies on the subject, these considerations remain speculative.
However, it is important to determine which oscillometric algorithm should be prioritized in critical care settings, where invasive measurement serves as the reference. This will be a secondary objective of this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a surgical intensive care unit having an arterial catheter
Key inclusion criteria (2 listed)
- - Patients having a catheter in the radial artery.
- and with stable BP over a 5-min period (no change in invasive MBP >10% and no change in vasoactive drugs)
Key exclusion criteria (11 listed)
- - Cardiac arrhythmia.
- Dysfunctional of the arterial catheter or waveform, suggesting signal over- or under-damping.
- Arm circumference > 42 cm (measured at mid-arm).
- Contraindication to BP measurement on the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access on the limb preventing cuff inflation, other).
- Patient's health status requiring urgent care incompatible with study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients of a surgical intensive care unitPatients of a surgical intensive care unit having an arterial catheter undergoing noninvasive measurements of BP in 3 situations (thick sleeve, thin sleeve, bare arm) and with 2 algorithms (for bare arm measurement only). | Other | – |
Primary outcome
To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
Time frame: Day 1
The measurement error will be considered acceptable if the current international standard, the AAMI/ESH/ISO standard, is met: mean error (bias) ≤ 5.0 mmHg and its standard deviation ≤ 8.0 mmHg. The reference BP will be measured using an arterial catheter, taking advantage of the fact that many critically ill patients already have one
13 secondary outcomes
To assess whether the non-invasive SBP and DBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve
Time frame: Day 1
To perform statistical comparisons of measurement errors based on sleeve presence, sleeve thickness, and reference algorithm.
Time frame: Day 1
To assess the risk associated with measurement errors for each condition.
Time frame: Day 1
To compare the ability of non-invasive measurements to detect hypotension (MBP or SBP <65 mmHg or <90 mmHg, respectively) and hypertension (MBP or SBP >90 mmHg or >140 mmHg, respectively).
Time frame: Day 1
To evaluate variability in cuff measurements within a given condition.
Time frame: Day 1
Analysis of subgroup differences based on BP levels (above vs. below median values).
Time frame: Day 1
Analysis of subgroup differences based on measurement error levels (above vs. below median values)
Time frame: Day 1
Analysis of subgroup differences based on BMI (above vs. below median and above vs. below 30 kg/m²)
Time frame: Day 1
Analysis of subgroup differences based on arm circumference (above vs. below median)
Time frame: Day 1
Analysis of subgroup differences based on age (above vs. below 60 years)
Time frame: Day 1
Analysis of subgroup differences based on age (above vs. below 60 years)
Time frame: Day 1
Analysis of subgroup differences based on presence of acute circulatory failure or not
Time frame: Day 1
Analysis of subgroup differences based on ventilation mode (mechanical vs. non-mechanical)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim LAKHAL, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether the non-invasive MBP measurement error is acceptable in either situation: bare arm, thick and thin sleeve (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.